Extensive experience in the development and and execution of analytical control strategies (drug substance and drug product) encompassing small molecule, peptide and oligonucleotide assets across the breadth of clinical development. Additionally, I have considerable experience in working with external partners with an emphasis on the development of OSD formulations inclusive of analytical, packaging, formulation and processing. Recently, I have taken an analytical leadership role in our sterile product development organization. While still leading an analytical team, I am also now leading multiple biologic drug product development teams that are accountable for FIH through commercial formulation/presentation development. Throughout this journey, I have a demonstrated track record of leading analytical teams, including staff development at all scientific levels while continuing to drive success in a matrix environment
Listed skills include Validation, Analytical Chemistry, Technology Transfer, Hplc, and 14 others.